Routine Care Equals Intense in Type 2 Diabetes

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Intensive multifactorial treatment might be burdensome for patients with type 2 diabetes who are identified by screening and are largely asymptomatic.

In this study, however, there were no differences in health status, well-being, quality of life, and treatment satisfaction between screen-detected type 2 diabetes patients receiving intensive treatment and those receiving routine care.

No differences were found in health status, well-being, quality of life, and treatment satisfaction between screen-detected type 2 diabetes patients receiving intensive treatment and those receiving routine care, a study reported.

Results of the Euroqol 5 Dimensions (EQ-5D) questionnaire -- which covers five domains of health -- showed that EQ-5D did not change between diagnosis and follow-up, with a median (interquartile range) of 0.85 (0.73-1.00) at baseline and 0.85 (0.73-1.00) at follow-up, which occurred at an average of 5.7 years later, wrote Guy Rutten, MD, PhD, of the University Medical Center Utrecht in the Netherlands, and colleagues on Oct. 29 issue of Diabetologia.

These outcomes, from the Anglo-Danish-Dutch Study of Intensive Treatment in People with Screen Detected Diabetes in Primary Care (ADDITION-Europe) trial, "suggest that intensive treatment does not adversely affect patient-reported outcomes," they wrote.

Intensive treatment of hyperglycemia, hypertension, and dyslipidemia is known to cut the risk of cardiovascular events in half in patients with long-standing diabetes and microalbuminuria. But whether intensive treatment has a similar impact on newly diagnosed, asymptomatic disease, and whether intensive treatment will cause these patients stress that leads them to dissatisfaction with care has been an unknown, the investigators noted.

"Intensive multifactorial treatment might be burdensome for patients who are largely asymptomatic," they said. "Physicians might be reluctant to introduce intensive treatment, including recommendations to change multiple lifestyle behaviors and the prescription of several medications, which may lead to psychosocial stress and reduced satisfaction with treatment."

Patient-reported outcome measures, they continued, are valuable components in assessing the effectiveness of early treatment and have been used in the past to evaluate healthcare service and implement regulatory decision-making.

The UK Prospective Diabetes Study (UKPDS), for example, suggested that intensive treatment for elevated blood glucose levels and BP among patients newly diagnosed with type 2 diabetes didn't have a negative effect on quality of life. And the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial of intensive treatment for glycemic control in U.S. patients with long-standing type 2 diabetes was not associated with improvement in quality of life, but did lead to improvements in satisfaction with treatment.

The current cluster-randomized, parallel-group trial included 343 general practices in Denmark; Cambridge, England; Leicester, England; and the Netherlands. Within these practices, 3,057 asymptomatic patients between the ages of 40 and 69 were diagnosed with type 2 diabetes through screening. Of those, 1,678 were randomized to intensive treatment and 1,379 to routine care.

Treatment targets for the intensive treatment group were HbA1c <7.0% (53 mmol/mol), blood pressure ≤135/85 mmHg, cholesterol <5 mmol/L in the absence of a history of coronary heart disease, and cholesterol 4.5 mmol/L in patients with cardiovascular disease. People taking anti-hypertensive medication were also prescribed aspirin, and ACE inhibitors were recommended for those with cardiovascular disease or blood pressure >120/80mmHg.

Several patient-reported outcome measures were administered to study participants at follow-up, including the Euroqol-VAS (EQ-VAS), a visual analog scale, the Well-Being Questionnaire (W-BQ12), the 36-item Short Form Health Survey (SF-36), the Audit of Diabetes-Dependent Quality of Life 19 (ADDQoL 19) and the Diabetes Treatment Satisfaction questionnaire (DTSQ).

The authors did note some "heterogeneity" between centers, possibly because of variations in care delivery and differing patient populations, and, in the intensive treatment group, a nonsignificant 17% relative reduction of cardiovascular mortality and morbidity.

The trial occurred over a time span in which targets for blood pressure and cholesterol levels became stricter for diabetes patients, the authors wrote. This, they said, resulted in "smaller than expected differences between the routine care and intensive treatment groups, in terms of cardiovascular risk factors, prescribed medication, and cardiovascular disease outcomes."

Possibly because of these changes, the differences between the two groups were larger in the first years of the study, they said, and 1-year differences in intermediate outcomes between the routine care and intensive treatment groups weren't maintained at 5 years.

Still, at follow-up, more patients in the intensive treatment group had been prescribed aspirin, ACE inhibitors or angiotensin receptor blockers, glucose-lowering drugs, antihypertensive drugs, and lipid-lowering drugs.

There were some limitations to the study. Patients who completed all the questionnaires differed from those who did not, though these differences were small, not in one direction, and similar in the intensive treatment and routine care groups, the authors said. And most patient-reported outcome measures were not measured at baseline, so the investigators weren't able to measure changes in them over time.

The study had support from many organizations including the Wellcome Trust; the Medical Research Council; the NIHR Health Technology Assessment Programme; the National Health Service R&D support funding; the Danish National Health Services in the counties of Copenhagen, Aarhus, Ringkøbing, Ribe and South Jutland; Novo Nordisk Foundation; the Danish Centre for Evaluation and Health Technology Assessment; the Danish Medical Research Council; the Aarhus University Research Foundation; Pfizer Denmark; and GlaxoSmithKline Pharma Denmark.

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